Trial record 15 of 53 for:
Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo
This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey
First received: August 22, 2005
Last updated: August 6, 2008
Last verified: August 2008
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo
Primary Outcome Measures:
- Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)
Secondary Outcome Measures:
- Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
- Patient-Generated Global Assessment
- Skin texture assessment
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Vitiligo patients aged 18 years and older
- Vitiligo patients with evaluable lesions; duration of 3 months to 10 years.
- Disease interferes significantly with quality of life and/or involving 3% or more body surface area
- Subjects must have a negative tuberculin (TB) skin test at entry into the study
- If subject is a female of childbearing potential, she must agree to use adequate contraception (adequate contraception can include abstinence) and must have a negative serum pregnancy test the day of administration of study medication.
- If subject is a male and has reached puberty, he must agree to use adequate contraception during the study and for 1 month after discontinuation from study.
- Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections
- Subject must be able to give informed consent; must authorize release and use of protected health information; and, if applicable, must assent to participate prior to enrollment to this study.
These patients will not be eligible, even with a wash-out. Patients with previous or current exposure to Kineret will NOT be eligible, even with a wash-out. However, patients with prior or current exposure to biologics directed against T-cells (e.g. alefacept, efalizumab, siplizumab, etc.) will be eligible for enrollment into the study after a wash-out period of 4 weeks before first dose of study drug (baseline visit). It has to be protocol specific also.
- The subject has, in the Investigator's opinion, a chronic, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular (congestive heart failure [CHF] of any severity; myocardial infarction [MI], cerebrovascular accident [CVA] or transient ischemic attack [TIA] within 3 months of screening visit; unstable angina pectoris; uncontrolled hypertension [sitting systolic blood pressure (BP) < 80 mm Hg or > 160 or diastolic BP > 100 mm Hg]), or neurological disease; known systemic lupus erythematosus (SLE); diabetes; or any other concomitant medical condition that places the participant at risk by participating this study and/or that may interfere with the conduct of the study.
- Chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134368
|UMDNJ Psoriasis Center of Excellence
|New Brunswick, New Jersey, United States, 08903 |
University of Medicine and Dentistry New Jersey
||Alice Gottlieb, MD, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 22, 2005
||August 6, 2008
||United States: Food and Drug Administration
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents